Katakam Lakshmi Narasimha Rao, Dongala Thirupathi
Analytical Development, Saptalis Pharmaceuticals LLC, Hauppauge, New York, NY, USA.
Analytical Research & Development, Aurex Laboratories LLC, NJ, USA.
Biomed Chromatogr. 2020 Jul;34(7):e4827. doi: 10.1002/bmc.4827. Epub 2020 Apr 8.
The main aim of the study is to develop and validate a simple and rapid liquid chromatographic analytical method for simultaneous determination of trace level of un-sulfated alcohol impurities in sodium lauryl sulfate using high-performance liquid chromatography with a refractive index detector. The chromatographic separation was achieved using flow rate of 3.0 ml/min with a Waters Symmetry C (150 × 4.6 mm, 5 μm) column and 50°C as a column temperature. The mobile phase comprised milliQ water and acetonitrile in the ratio of 30:70 v/v respectively. The detection was performed using a refractive index detector at a sensitivity of 64. The resolutions among n-decanol, n-dodecanol, n-tetradecanol, n-hexadecanol, and n-heptadecanol were found to be >4. Regression analysis showed a correlation coefficient for the stated compounds of >0.999. The validated HPLC method was utilized effectively for the estimation of un-sulfated alcohols in quality control labs for commercial release of sodium lauryl sulfate.
本研究的主要目的是开发并验证一种简单快速的液相色谱分析方法，用于使用配备示差折光检测器的高效液相色谱法同时测定月桂醇硫酸酯钠中痕量的未硫酸化醇杂质。使用流速为3.0毫升/分钟、Waters Symmetry C（150×4.6毫米，5微米）色谱柱以及50°C作为柱温实现色谱分离。流动相由超纯水和乙腈分别按30:70 v/v的比例组成。使用示差折光检测器以64的灵敏度进行检测。发现正癸醇、正十二醇、正十四醇、正十六醇和正十七醇之间的分离度>4。回归分析表明所述化合物的相关系数>0.999。经过验证的高效液相色谱法有效地用于质量控制实验室中对月桂醇硫酸酯钠商业放行时未硫酸化醇的测定。
